Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091687
Company: TRIS PHARMA INC

Products on ANDA 091687

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	AA	No	No
PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE	PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML	TABLET, CHEWABLE, TABLET, CAPSULE; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091687

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Therapeutic Equivalents for ANDA 091687

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

SYRUP;ORAL; 15MG/5ML;6.25MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROMETHAZINE DM	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	040649	SLATE RUN PHARMA
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	090575	AMNEAL PHARMS
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	091687	TRIS PHARMA INC
PROMETHAZINE W/ DEXTROMETHORPHAN	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP;ORAL	Prescription	No	AA	088864	WOCKHARDT BIO AG

PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

There are no Therapeutic Equivalents.